The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Enfit Oral / Enteral Syringe.
| Device ID | K190502 |
| 510k Number | K190502 |
| Device Name: | ENFit Oral / Enteral Syringe |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin City, CN 214425 |
| Contact | Xinyan Ruan |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-01 |
| Decision Date | 2019-08-06 |